{"id":5378,"date":"2015-07-11T17:18:00","date_gmt":"2015-07-11T15:18:00","guid":{"rendered":"https:\/\/faus-moliner.com\/?p=5378"},"modified":"2016-03-04T20:39:25","modified_gmt":"2016-03-04T18:39:25","slug":"substitution-of-medicinal-products-and-individual-rights-of-patients-2","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/substitution-of-medicinal-products-and-individual-rights-of-patients-2\/","title":{"rendered":"Substitution of medicinal products and individual rights of patients"},"content":{"rendered":"<p><strong>Background<\/strong><\/p>\n<p>This case begun when a doctor treating a patient with Parkinson came to the conclusion that, in this specific case, the generic medicinal product which the patient was getting from the pharmacy did not have the same effect\u00a0as the branded product which the doctor had prescribed. The substitution had been carried out by the pharmacist in a correct legal manner,\u00a0because the branded product had a price higher than the generic. However, given the circumstances, the doctor encouraged the patient to buy the branded product, which would not be reimbursed, and to file a claim for reimbursement later on.<\/p>\n<p><strong>The Law and individual rights<\/strong><\/p>\n<p>The Court\u00a0that analysed this case\u00a0ruled\u00a0in favour of\u00a0the patient, basing the decision on the need to protect\u00a0his individual rights. According to the Court, what is crucial to resolve this case\u00a0is not that the\u00a0pharmacy\u00a0was obliged to dispatch the generic product\u00a0due to its lower price; but the fact that the patient had the right\u00a0to protect his health\u00a0and to obtain the\u00a0branded product prescribed by the Neurology Service\u00a0that was treating him if, in his case, the result obtained with the branded product were better than those obtained with the generic.<\/p>\n<p>According to the Court the protection of the individual right of the patient is contemplated by Article\u00a085 of Law 29\/2006 on prescription, dispensation and\u00a0substitution; because according to this article\u00a0the principle\u00a0that must prevail is that\u00a0the prescription must be made in the most\u00a0appropriate manner\u00a0for the benefit of patients.<\/p>\n<p>The Court also recalls\u00a0that the same law\u00a0provides that the sustainability of the system must be protected\u00a0and it envisages that, because of this, the prescription and dispensation of the branded product is possible only if its price is not higher than the one of the generic one. However, according to the judgement,\u00a0this rule\u00a0has to be disregarded\u00a0in the case of non substitutable products, and\u00a0in order to determine whether a medicinal product is substitutable or not,\u00a0it is possible and even necessary\u00a0to take into account the individual situation of each patient. If the condition of a patient treated\u00a0with a\u00a0branded product\u00a0aggravates when he starts being treated with the generic version, the Court says, these products must be considered as non-substitutable at least in the case of the specific patient.<\/p>\n<p><strong>Selection and Substitution\u00a0of biological products<\/strong><\/p>\n<p>The ideas expressed in this judgment contribute to the debate\u00a0on the situation of patients treated\u00a0with\u00a0biological medicinal products. For these products, where prescribing by brand name\u00a0is compulsory,\u00a0and\u00a0where identification\u00a0of the brand\u00a0and\u00a0of the batch of the product administered to the patient is required for pharmacovigilance purposes,\u00a0substitution without\u00a0the consent of the patient and\u00a0the prescribing doctor is not only illegal\u00a0but it also\u00a0infringes\u00a0the\u00a0individual rights\u00a0of patients\u00a0recognized in the Constitution. This applies to\u00a0any type\u00a0of selecting measure that\u00a0implies generalizing\u00a0substitution or\u00a0that\u00a0makes the prescribers treat\u00a0the new\u00a0patients with a\u00a0biologic medicinal product to the detriment of another. The doctor\u2019s criterion, and\u00a0the patient\u2019s right\u00a0to be informed\u00a0and to be able to choose\u00a0from the available alternatives must prevail in all cases, and especially\u00a0in this one.<\/p>\n<div class=\"clear\"><\/div>\n<div class=\"gdlr-space\" style=\"margin-top: 40px;\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Background This case begun when a doctor treating a patient with Parkinson came to the conclusion that, in this specific case, the generic medicinal product which the patient was getting from the pharmacy did not have the same effect\u00a0as the branded product which the doctor had prescribed. The substitution had been carried out by the&#8230; <\/p>\n<div class=\"clear\"><\/div>\n<p><a href=\"https:\/\/faus-moliner.com\/en\/substitution-of-medicinal-products-and-individual-rights-of-patients-2\/\" class=\"excerpt-read-more\">Read More<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[221,81,72,389,390],"tags":[],"coauthors":[105],"class_list":["post-5378","post","type-post","status-publish","format-standard","hentry","category-biosimilars-2","category-biosimilars","category-capsulas-en","category-generics","category-generics-2"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Substitution of medicinal products and individual rights of patients - Faus Moliner<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/faus-moliner.com\/en\/substitution-of-medicinal-products-and-individual-rights-of-patients-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Substitution of medicinal products and individual rights of patients - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Background This case begun when a doctor treating a patient with Parkinson came to the conclusion that, in this specific case, the generic medicinal product which the patient was getting from the pharmacy did not have the same effect\u00a0as the branded product which the doctor had prescribed. The substitution had been carried out by the... 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